Provecta HD Single Post Mounting Plate

Basic Information

• Brand Name: Provecta HD Single Post Mounting Plate
• Primary DI: D678A63890
• Version / Model: A6389
• Company Name: AIR TECHNIQUES, INC.
• Labeler DUNS: 043835081
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-11
• Public Version: 1
• Public Version Date: 2023-07-19
• Public Version Status: New
• Public Device Record Key: a3246799-c0af-4693-8dda-c43bbe909177

Device Description

The Provecta HD Single Post Mounting Plate is used to secure the Provecta HD X-ray unit onto a facility wall with 4"x4" wood wall studs or a single or double 2"x4".

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYB	Tube Mount, X-Ray, Diagnostic	Radiology	892.1770	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65120	Custom-made medical device mount	A structure intended to be permanently-fixed to the ceiling and/or wall to support/stow a medical device(s) [e.g., light, monitor, surgical instruments] or stow/provide medical supplies. It is designed with specific characteristics as requested by a healthcare professional to meet the requirements of a specific facility. It may incorporate a pole, rack, shelves, electricity supply sockets, gas outlets, and/or enable dynamic positioning (e.g., with dynamic arms, sliding bracket); the device(s) to be mounted is not included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D678A63361	HIBCC	Box	1	In Commercial Distribution
Primary	D678A63890	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]